Federal Register / Vol. 76, No. 250 / Thursday, December 29, 2011 / Proposed Rules 81899 

PART 199—[AMENDED] 

1. The authority citation for Part 199 

continues to read as follows: 

Authority: 5 U.S.C. 301; 10 U.S.C. chapter 

55. 

2. Section 199.5 is amended by 

adding paragraph (c)(8)(iv) to read as 

follows: 

§ 199.5 TRICARE Extended Care Health 

Option (ECHO). 

* * * * * 

(c) * * * 

(8) * * * 

(iv) Applied Behavior Analysis (ABA) 

for ECHO-registered beneficiaries with 

an Autism Spectrum Disorder. Applied 

Behavior Analysis (ABA) is an ‘‘Other 

service’’ as that term is used in 10 

U.S.C. 1079(e), that may be reimbursed 

to an applied behavior analysis 

authorized provider to address the 

effects of an Autism Spectrum Disorder. 

Reimbursement for ABA services will be 

as determined by the Director, TRICARE 

Management Activity. 

(A) Services provided by this 

paragraph are subject to the 

requirements of paragraph (d)(10) of this 

section. 

(B) Definition of specific terms used 

in this paragraph and Section 199.6 of 

this part. 

(1) Applied Behavior Analysis (ABA) 

Authorized Provider. An individual, a 

corporation, a foundation, or a public 

entity meeting the requirements of 

§ 199.6(e)(2)(iv) of this part who or that 

provides ABA services to ECHOregistered beneficiaries diagnosed with 

an Autism Spectrum Disorder. 

(2) Applied Behavior Analysis (ABA) 

Services. Such non-medical services 

determined by the Director, TMA to be 

appropriate to reduce the disabling 

effects of ASD for ECHO-registered 

beneficiaries, which may include, but 

are not limited to: conducting the initial 

and ongoing Functional Behavioral 

Assessments and Analysis; developing 

and revising as necessary the Behavior 

Plan that details the ABA intervention 

services and methods to be used; 

supervising or directing ABA Tutor(s); 

training the beneficiary’s primary 

caregivers to reinforce the interventions 

detailed in the Behavior Plan; and 

periodically reporting the beneficiary’s 

progress to the primary caregivers. 

(3) Applied Behavior Analysis (ABA) 

Supervisor. An individual Applied 

Behavior Analysis (ABA) Authorized 

Provider who provides ABA Services 

through the supervision and direction of 

ABA Tutors. Only individuals who are 

Applied Behavior Analysis (ABA) 

Authorized Providers may act as 

Supervisors. Corporations, foundations 

or public entities may not act as ABA 

Supervisors. 

(4) Applied Behavior Analysis (ABA) 

Tutor. An individual who renders oneon-one ABA interventions to a TRICARE 

beneficiary diagnosed with an Autism 

Spectrum Disorder. ABA Tutors are not 

considered an ‘‘Authorized Provider’’ 

(refer to § 199.2 of this part) or an 

‘‘Authorized Applied Behavior Analysis 

(ABA) Provider’’ and are not eligible for 

direct reimbursement by TRICARE. 

(5) Autism Spectrum Disorders. The 

Pervasive Development Disorders listed 

in the Diagnostic and Statistical Manual 

of Mental Disorders, [DSM–IV–TR 

(fourth edition, text revision), 2000], or 

a superseding current edition of the 

DSM, specifically, ‘‘Autistic Disorder’’, 

‘‘Rett’s Disorder’’, Childhood 

Disintegrative Disorder’’, ‘‘Asperger’s 

Disorder’’, and ‘‘Pervasive Development 

Disorder Not Otherwise Specified 

(including Atypical Autism)’’Applied 

Behavior Analysis (ABA) Authorized 

Provider. 

* * * * * 

3. Section 199.6 is amended by 

adding paragraphs (e)(2)(iv) through 

(e)(2)(iv)(D) in to read as follows: 

§ 199.6 TRICARE-Authorized Providers. 

* * * * * 

(e) * * * 

(2) * * * 

(iv) ECHO Applied Behavior Analysis 

(ABA) Authorized Provider. 

(A) The following are authorized 

providers of Applied Behavior Analysis 

(ABA) services authorized by 

§ 199.5(c)(8)(iv) of this part to address 

the effects of a diagnosed Autism 

Spectrum Disorder (ASD): 

(1) Psychiatrists, clinical 

psychologists, certified psychiatric 

nurse specialists, and clinical social 

workers who provide ABA services 

within the scope of their license as an 

individual professional provider. 

(2) Individuals who meet all ABArelated applicable licensing or other 

regulatory requirements of the state, 

county, municipality, or other political 

jurisdiction in which ABA services are 

rendered. 

(3) Where such licensing or regulatory 

requirements referenced in paragraph 

(e)(2)(iv)(A)(2) of this section do not 

exist, an individual who maintains 

current certification by the Behavior 

Analyst Certification Board (BACB). 

(4) A corporation, foundation, or 

public entity that renders ABA services 

and that meets all applicable licensing 

or other regulatory requirements of the 

state, county, municipality, or other 

political jurisdiction in which ABA 

services are rendered. 

(B) All providers under paragraph 

(e)(2)(iv)(A) of this section shall 

maintain a current Participation 

Agreement with the Director, TRICARE 

Management Activity. 

(C) Reimbursement for ABA Services 

may be made to the following: 

(1) ABA Authorized Providers under 

paragraphs (e)(2)(iv)(A)(1) through (3) of 

this section for ABA Services provided 

by themselves directly to ECHOregistered beneficiaries or for the ABA 

Services rendered by ABA Tutors under 

their supervision and direction. 

(2) ABA Authorized Providers under 

paragraph (e)(2)(iv)(A)(4) of this section 

for ABA Services provided to ECHOregistered beneficiaries when rendered 

in accordance with the requirements of 

this Section by individuals employed by 

or under contract with an ABA 

Authorized Provider described in 

paragraph (e)(2)(iv)(A)(4) of this section. 

Note: Tutors shall meet all requirements 

established by the Director, TRICARE 

Management Activity. Tutors are not ‘‘ECHO 

Applied Behavior Analysis (ABA) 

Authorized Providers’’ and are not eligible 

for direct TRICARE reimbursement for ABA 

services they render. 

(D) TRICARE reimbursement for ABA 

services shall be the TRICARE allowed 

amount as determined by the Director, 

TRICARE Management Activity. 

* * * * * 

Dated: December 23, 2011. 

Aaron Siegel, 

Alternate OSD Federal Register Liaison 

Officer, Department of Defense. 

[FR Doc. 2011–33384 Filed 12–28–11; 8:45 am] 

BILLING CODE 5001–06–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

[DOD–2011–HA–0085] 

RIN 0720–AB54 

32 CFR Part 199 

TRICARE; Removal of the Prohibition 

to Use Addictive Drugs in the 

Maintenance Treatment of Substance 

Dependence in TRICARE Beneficiaries 

AGENCY: Office of the Secretary, 

Department of Defense. 

ACTION: Proposed rule. 

SUMMARY: This rule proposes revisions 

to remove the exclusion of drug abuse 

maintenance programs and allow as part 

of a comprehensive treatment plan for 

an individual with substance 

dependence, the substitution of a 

therapeutic drug with addictive 

potential for a drug of addiction (e.g. the 


wreier-aviles on DSK3TPTVN1PROD with PROPOSALS
81900 Federal Register / Vol. 76, No. 250 / Thursday, December 29, 2011 / Proposed Rules 

substitution of methadone for heroin). 

The current regulation prohibits drug 

maintenance programs where one 

addictive substance is substituted for 

another. However, this prohibition of 

maintenance treatment of substance 

dependence utilizing a specific category 

of psychoactive agent is outdated and 

fails to recognize the accumulated 

medical evidence supporting certain 

maintenance programs as one 

component of the continuum of care 

necessary for the effective treatment of 

substance dependence. Current medical 

evidence shows that this is medically or 

psychologically necessary and integral 

to the safe and effective treatment of 

drug abuse as is generally required for 

all treatment benefits for inclusion in 

the TRICARE benefit. 

DATES: Written comments received at 

the address indicated below by February 

27, 2012 will be accepted. 

ADDRESSES: You may submit comments, 

identified by docket number and or 

Regulatory Information Number (RIN) 

number and title, by either of the 

following methods: 

• Federal eRulemaking Portal: 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Federal Docket Management 

System Office, 1160 Defense Pentagon, 

OSD Mailroom 3C843, Washington, DC 

20301–1160. 

Instructions: All submissions received 

must include the agency name and 

docket number or RIN for this Federal 

Register document. The general policy 

for comments and other submissions 

from members of the public is to make 

these submissions available for public 

viewing on the Internet at http:// 

www.regulations.gov as they are 

received without change, including any 

personal identifiers or contact 

information. 

FOR FURTHER INFORMATION CONTACT: 

CAPT Robert DeMartino, TRICARE 

Management Activity, Office of the 

Chief Medical Officer, telephone (703) 

681–0070. 

SUPPLEMENTARY INFORMATION: 

Contingency operations involving 

DoD personnel are now in their tenth 

year. The advances in battlefield injury 

protection and medicine have 

drastically reduced the number of 

battlefield deaths and have returned our 

Service members home, injured, but 

prepared to recover. For many, pain 

related to injuries must be treated for 

many months and such long-term use of 

pain medications has put our Service 

members using those medicines at risk 

for dependence. This reality makes it 

ever more important to ensure that all 

safe and effective treatments for 

substance dependence are available to 

our Service members. 

The current TRICARE regulation 

prohibits drug maintenance programs 

where a therapeutic drug with addictive 

potential is substituted for a drug of 

addiction. However, medicine is 

constantly evolving including in the 

area of drug addiction treatments. In the 

past, there was not sufficient reliable 

evidence as that term is used in the 

TRICARE regulations at 32 CFR 

199.4(g)(15), to establish that the 

substitution of one addictive drug for 

another was an effective part of a drug 

treatment program. 

The changes proposed to the CFR will 

remove the specific prohibition on 

coverage of drug maintenance programs 

when one addictive drug is substituted 

for another, thereby allowing treatment 

regimens involving the substitution of 

one addictive drug for another when it 

is a medical necessity and appropriate 

for an individual beneficiary. 

Regulatory Procedures 

Executive Order 12866 and Executive 

Order 13563 

Executive Orders 13563 and 12866 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). Executive Order 13563 

emphasizes the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. This rule 

has been designated a ‘‘significant 

regulatory action’’ although not 

economically significant, under section 

3(f) of Executive Order 12866. 

Accordingly, the rule has been reviewed 

by the Office of Management and 

Budget. 

Public Law 104–4, Section 202, 

‘‘Unfunded Mandates Reform Act’’ 

Section 202 of Public Law 104–4, 

‘‘Unfunded Mandates Reform Act,’’ 

requires that an analysis be performed 

to determine whether any federal 

mandate may result in the expenditure 

by State, local and tribal governments, 

in the aggregate, or by the private sector 

of $100 million in any one year. It has 

been certified that this proposed rule 

does not contain a Federal mandate that 

may result in the expenditure by State, 

local and tribal governments, in 

aggregate, or by the private sector, of 

$100 million or more in any one year, 

and thus this proposed rule is not 

subject to this requirement. 

Public Law 96–354, ‘‘Regulatory 

Flexibility Act’’ (RFA) (5 U.S.C. 601) 

Public Law 96–354, ‘‘Regulatory 

Flexibility Act’’ (RFA) (5 U.S.C. 601), 

requires that each Federal agency 

prepare a regulatory flexibility analysis 

when the agency issues a regulation 

which would have a significant impact 

on a substantial number of small 

entities. This proposed rule is not an 

economically significant regulatory 

action, and it has been certified that it 

will not have a significant impact on a 

substantial number of small entities. 

Therefore, this proposed rule is not 

subject to the requirements of the RFA. 

Public Law 96–511, ‘‘Paperwork 

Reduction Act’’ (44 U.S.C. Chapter 35) 

This rule does not contain a 

‘‘collection of information’’ 

requirement, and will not impose 

additional information collection 

requirements on the public under Public 

Law 96–511, ‘‘Paperwork Reduction 

Act’’ (44 U.S.C. chapter 35). 

Executive Order 13132, ‘‘Federalism’’ 

E.O. 13132, ‘‘Federalism,’’ requires 

that an impact analysis be performed to 

determine whether the rule has 

federalism implications that would have 

substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. It has been 

certified that this proposed rule does 

not have federalism implications, as set 

forth in E.O. 13132. 

List of Subjects in 32 CFR Part 199 

Claims, Dental health, Health care, 

Health insurance, Individuals with 

disabilities, Military personnel. 

Accordingly, 32 CFR part 199 is 

proposed to be amended as follows: 

PART 199—[AMENDED] 

1. The authority citation for Part 199 

continues to read as follows: 

Authority: 5 U.S.C. 301; 10 U.S.C. chapter 

55. 

2. Section 199.4 is amended by 

revising paragraph (e)(11) introductory 

text, and removing and reserving 

paragraph (e)(11)(ii), to read as follows: 

§ 199.4 Basic program benefits. * * * 

* * * * * 

(e) * * * 

(11) Drug abuse. Under the Basic 

Program, benefits may be extended for 

medically necessary prescription drugs 


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Federal Register / Vol. 76, No. 250 / Thursday, December 29, 2011 / Proposed Rules 81901 

required in the treatment of an illness or 

injury or in connection with maternity 

care (refer to paragraph (d) of this 

section). However, CHAMPUS benefits 

cannot be authorized to support or 

maintain an existing or potential drug 

abuse situation whether or not the drugs 

(under other circumstances) are eligible 

for benefit consideration and whether or 

not obtained by legal means. Drugs, 

including addictive drugs, prescribed to 

beneficiaries undergoing medically 

supervised treatment for a substance use 

disorder are not considered to be in 

support of, or to maintain, an existing or 

potential drug abuse situation and are 

allowed. The Director, TRICARE 

Management Activity may prescribe 

appropriate policies to implement this 

prescription drug benefit for those 

undergoing medically supervised 

treatment for a substance use disorder. 

* * * * * 

(ii) [Reserved] 

* * * * * 

Dated: December 21, 2011. 

Aaron Siegel, 

Alternate OSD Federal Register Liaison 

Officer, Department of Defense. 

[FR Doc. 2011–33106 Filed 12–28–11; 8:45 am] 

BILLING CODE 5001–06–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R04–OAR–2011–0029–201163; FRL– 

9613–1] 

Approval and Promulgation of 

Implementation Plans and 

Designations of Areas for Air Quality 

Planning Purposes; North Carolina and 

South Carolina; Charlotte; 

Determination of Attainment by 

Applicable Attainment Date for the 

1997 8-Hour Ozone Standards 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing to 

determine pursuant to the Clean Air Act 

(CAA), that the Charlotte-Gastonia-Rock 

Hill, North Carolina-South Carolina, 

ozone nonattainment area (hereafter 

referred to as ‘‘the bi-state Charlotte 

Area’’ or ‘‘the Area’’) has attained the 

1997 8-hour ozone national ambient air 

quality standards (NAAQS) by its 

applicable attainment date of June 15, 

2011. The determination of attainment 

was made by EPA on November 15, 

2011, based on quality-assured and 

certified monitoring data for the 2008– 

2010 monitoring period. EPA is now 

proposing to find that the bi-state 

Charlotte Area attained the 1997 8-hour 

ozone NAAQS by its applicable 

attainment date. EPA is proposing this 

action because it is consistent with the 

CAA and its implementing regulations. 

DATES: Comments must be received on 

or before January 30, 2012. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R04– 

OAR–2011–0029, by one of the 

following methods: 

1. www.regulations.gov: Follow the 

on-line instructions for submitting 

comments. 

2. Email: benjamin.lynorae@epa.gov. 

3. Fax: (404) 562–9019. 

4. Mail: EPA–R04–OAR–2011–0029, 

Regulatory Development Section, Air 

Planning Branch, Air, Pesticides and 

Toxics Management Division, U.S. 

Environmental Protection Agency, 

Region 4, 61 Forsyth Street SW., 

Atlanta, Georgia 30303–8960. 

5. Hand Delivery or Courier: Ms. 

Lynorae Benjamin, Chief, Regulatory 

Development Section, Air Planning 

Branch, Air, Pesticides and Toxics 

Management Division, U.S. 

Environmental Protection Agency, 

Region 4, 61 Forsyth Street SW., 

Atlanta, Georgia 30303–8960. Such 

deliveries are only accepted during the 

Regional Office’s normal hours of 

operation. The Regional Office’s official 

hours of business are Monday through 

Friday, 8:30 to 4:30, excluding Federal 

holidays. 

Instructions: Direct your comments to 

Docket ID No. ‘‘EPA–R04–OAR–2011– 

0029.’’ EPA’s policy is that all 

comments received will be included in 

the public docket without change and 

may be made available online at 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit through 

www.regulations.gov or email, 

information that you consider to be CBI 

or otherwise protected. The 

www.regulations.gov Web site is an 

‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an email comment directly 

to EPA without going through 

www.regulations.gov, your email 

address will be automatically captured 

and included as part of the comment 

that is placed in the public docket and 

made available on the Internet. If you 

submit an electronic comment, EPA 

recommends that you include your 

name and other contact information in 

the body of your comment and with any 

disk or CD–ROM you submit. If EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, EPA may not be 

able to consider your comment. 

Electronic files should avoid the use of 

special characters, any form of 

encryption, and be free of any defects or 

viruses. For additional information 

about EPA’s public docket visit the EPA 

Docket Center homepage at http:// 

www.epa.gov/epahome/dockets.htm. 

Docket: All documents in the 

electronic docket are listed in the 

www.regulations.gov index. Although 

listed in the index, some information is 

not publicly available, i.e., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either 

electronically in www.regulations.gov or 

in hard copy at the Regulatory 

Development Section, Air Planning 

Branch, Air, Pesticides and Toxics 

Management Division, U.S. 

Environmental Protection Agency, 

Region 4, 61 Forsyth Street SW., 

Atlanta, Georgia 30303–8960. EPA 

requests that if at all possible, you 

contact the person listed in the FOR

FURTHER INFORMATION CONTACT section to 

schedule your inspection. The Regional 

Office’s official hours of business are 

Monday through Friday, 8:30 to 4:30, 

excluding Federal holidays. 

FOR FURTHER INFORMATION CONTACT: For 

information regarding this attainment 

determination, contact Mr. Sean 

Lakeman, Regulatory Development 

Section, Air Planning Branch, Air, 

Pesticides and Toxics Management 

Division, U.S. Environmental Protection 

Agency, Region 4, 61 Forsyth Street 

SW., Atlanta, Georgia 30303–8960. 

Telephone number: (404) 562–9043; 

email address: lakeman.sean@epa.gov. 

For information regarding 8-hour ozone 

NAAQS, contact Ms. Jane Spann, 

Regulatory Development Section, at the 

same address above. Telephone number: 

(404) 562–9029; email address: 

spann.jane@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. What action is EPA taking? 

II. What is the background for this action? 

III. What is the air quality in the bi-state 

Charlotte Area for the 1997 8-hour ozone 

NAAQS for the 2008–2010 monitoring 

period? 

IV. What is the proposed action and what is 

the effect of this action? 

V. Statutory and Executive Order Reviews 


wreier-aviles on DSK3TPTVN1PROD with PROPOSALS